Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOWPOROSITY VALVED CONDUIT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail assays

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 734A POSTERIOR CHAMBER INTRAOCULAR LENSES

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CM(TM) LENSES MODEL 722D

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT (MODEL 105)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel Solid Tumors with dMMR status)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY